{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,24]],"date-time":"2026-10-24T15:43:08Z","timestamp":1792856588646,"version":"4.5.0"},"reference-count":28,"publisher":"Springer Science and Business Media LLC","issue":"3","license":[{"start":{"date-parts":[[2024,11,14]],"date-time":"2024-11-14T00:00:00Z","timestamp":1731542400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2024,11,14]],"date-time":"2024-11-14T00:00:00Z","timestamp":1731542400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/100004324","name":"Astellas Pharma US","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004324","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Graefes Arch Clin Exp Ophthalmol"],"published-print":{"date-parts":[[2025,3]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Purpose<\/jats:title>\n                    <jats:p>Determine rates of progression of incomplete retinal pigment epithelium and outer retinal atrophy (iRORA) to complete retinal pigment epithelium and outer retinal atrophy (cRORA) and rates of progression of drusen to iRORA\/cRORA in eyes with geographic atrophy (GA) treated with avacincaptad pegol (ACP).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Post hoc analysis of the GATHER1 prospective, randomized, double-masked Phase II\/III study that evaluated ACP 2\u00a0mg vs. sham. Optical coherence tomography (OCT) data from GATHER1 were transferred to the Doheny Image Reading and Research Lab for masked analysis by readers experienced with Classification of Atrophy Meeting (CAM) grading features. Regions of OCT volume scans more than 500\u00a0\u00b5m from the border of GA lesions were evaluated at baseline and at months 6, 12, and 18. Participants with iRORA and\/or drusen (\u2265\u200940\u00a0\u00b5m height on OCT) at baseline were included in the analysis.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>The proportion of eyes progressing from iRORA to cRORA in the ACP 2\u00a0mg group was 5.0%, 15.0%, and 20.0% at months 6, 12, and 18 respectively, as compared with 11.8%, 30.2%, and 41.8% of eyes in the sham group. The proportion of ACP 2\u00a0mg-treated eyes progressing from drusen to iRORA or cRORA was 3.8%, 7.6%, and 7.6% at months 6, 12, and 18 compared with 15.9%, 18.1%, and 27.2% of sham-treated eyes.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Rates of progression from iRORA to cRORA and drusen to iRORA\/cRORA were reduced in eyes treated with ACP 2\u00a0mg vs. sham, with increasing separation between groups over time, suggesting early intervention may slow disease progression.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p>ClinicalTrials.gov identifier: NCT02686658. Date of registration: February 16, 2016.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Key messages<\/jats:title>\n                    <jats:p>\n                      <jats:bold>\n                        <jats:italic>What is known<\/jats:italic>\n                      <\/jats:bold>\n                      <jats:list list-type=\"bullet\">\n                        <jats:list-item>\n                          <jats:p>Geographic atrophy is an advanced form of age-related macular\u00a0degeneration (AMD) that leads to irreversible vision loss, presenting a significant public health unmet need.<\/jats:p>\n                        <\/jats:list-item>\n                        <jats:list-item>\n                          <jats:p>The Classification of Atrophy Meeting (CAM) group recommended a new nomenclature for advanced AMD lesions, based on the affected anatomical layers on optical coherence tomography. Accordingly, the terms incomplete retinal pigment epithelium and outer retinal atrophy (iRORA) and complete retinal pigment epithelium and outer retinal atrophy (cRORA) were introduced (Guymer et al., Ophthalmology 127:394\u2013409, 2020; Sadda et al., Ophthalmology 125:537\u2013548, 2018).<\/jats:p>\n                        <\/jats:list-item>\n                      <\/jats:list>\n                    <\/jats:p>\n                    <jats:p>\n                      <jats:bold>\n                        <jats:italic>What is new<\/jats:italic>\n                      <\/jats:bold>\n                      <jats:list list-type=\"bullet\">\n                        <jats:list-item>\n                          <jats:p>GATHER1 post hoc analysis shows that treatment with avacincaptad pegol (ACP) 2\u00a0mg decreases the proportion of eyes that progress from iRORA to cRORA, and from drusen to iRORA or cRORA, compared with sham, over 6, 12, and 18\u00a0months.<\/jats:p>\n                        <\/jats:list-item>\n                        <jats:list-item>\n                          <jats:p>These findings suggest a potential role for ACP in delaying the progression of existing pre-atrophic AMD lesions<\/jats:p>\n                        <\/jats:list-item>\n                      <\/jats:list>\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s00417-024-06676-7","type":"journal-article","created":{"date-parts":[[2024,11,13]],"date-time":"2024-11-13T22:54:56Z","timestamp":1731538496000},"page":"669-677","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":13,"title":["Progression to complete retinal pigment epithelium and outer retinal atrophy (cRORA): post hoc analysis of the GATHER1 trial"],"prefix":"10.1007","volume":"263","author":[{"given":"Giulia","family":"Corradetti","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ayesha","family":"Karamat","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sowmya","family":"Srinivas","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sophiana","family":"Lindenberg","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Swetha B.","family":"Velaga","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Federico","family":"Corvi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yamini","family":"Attiku","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Muneeswar Gupta","family":"Nittala","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dhaval","family":"Desai","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Liansheng","family":"Zhu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dina","family":"Abulon","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4939-3306","authenticated-orcid":false,"given":"SriniVas R.","family":"Sadda","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2024,11,14]]},"reference":[{"key":"6676_CR1","doi-asserted-by":"publisher","first-page":"369","DOI":"10.1016\/j.ophtha.2017.08.038","volume":"125","author":"M Fleckenstein","year":"2018","unstructured":"Fleckenstein M, Mitchell P, Freund KB, Sadda S, Holz FG, Brittain C, Henry EC, Ferrara D (2018) The progression of geographic atrophy secondary to age-related macular degeneration. 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The appropriate ethics committee or institutional review board at each study center involved in the study (80 centers)\u00a0approved the protocol [\n                      \n                      ].","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"Written informed consent was obtained from all participants [\n                      \n                      ].","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}},{"value":"SriniVas R Sadda- although the author is the editor of the journal, there was no involvement with the peer review process for this article.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Disclosure statement"}},{"value":"GC has received lecture fees from Nidek. AK, SS, SL, SBV, FC, YA, and MGN have no financial disclosures. SR Sadda has consulted\/advised for: Apellis Pharmaceuticals, Inc.; Amgen Inc.; AbbVie\/Allergan, Inc.; Samsung Bioepis; Biogen; Boehringer Ingelheim; Iveric Bio; Novartis; Roche\/Genentech; Bayer Healthcare Pharmaceuticals; Regeneron Pharmaceuticals, Inc.; Pfizer Inc.; Astellas; Nanoscope Therapeutics; Janssen Pharmaceuticals, Inc.; CenterVue, Inc.; Optos, Inc.; and Heidelberg Engineering; has received lecture fees\/speakers bureau fees from: Heidelberg Engineering; Roche\/Genentech; Novartis; and Optos, Inc.; and has received research equipment from: CenterVue, Inc.; Optos, Inc.; Carl Zeiss Meditec; Topcon Medical Systems, Inc.; Heidelberg Engineering; and Nidek Inc. SR Sadda, the corresponding author, is an editor of the journal; however, there was no involvement with the peer review process for this article. DD and LZ are former employees of Astellas, and DA is an employee of Astellas.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}]}}